10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
External Hex Tool .050", Long
FDA UDI
STERNGOLD DENTAL LLC·00841549117978·For use with the 30 N cm Torque Wrench to tight...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113368·3M™ Victory Series™ Second Molar Bands, 905-229...
PACING/PSI KIT: 5 FR/6 FR 2-L
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015
BARD CONFORMACATH FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·July 10, 2015
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
SPIDER CERVICAL PLATING (SCP) SYSTEM
FDA Adverse Event
Malfunction
·X-SPINE SYSTEMS, INC.·Product code KWQ·July 1, 2014
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021